FDA Adverse Event
Summary report: N
6000023-1998-00039
MDR report key: 181157
·
Received July 10, 1998
Report
- Report Number
- 6000023-1998-00039
- Date Received
- July 10, 1998
- Date of Event
- March 12, 1998
- Product Code
- LWS
- Removal / Correction Number
- NI
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
AFTER DELIVERING SHOCK, CAPACITOR COULD NOT BE RECHARGED DUE TO CHARGE CIRCUIT TIME OUT. INSULATION DEFECT JUST BELOW BIFURCATION; LEAD STRONGLY KINKED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LWS | 7218C | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |